DRUG DESCRIPTION

Plavix (clopidogrel bisulfate) is a thienopyridine class inhibitor of P2Y12
ADP platelet receptors. Chemically it is methyl (+)-(S)-?-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)acetate
sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2S•H2SO4
and its molecular weight is 419.9.

The structural formula is as follows:

Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble
in water at neutral pH but freely soluble at pH 1. It also dissolves freely
in methanol, dissolves sparingly in methylene chloride, and is practically insoluble
in ethyl ether. It has a specific optical rotation of about +56°.

Plavix for oral administration is provided as either pink, round, biconvex,
debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate
which is the molar equivalent of 75 mg of clopidogrel base or pink, oblong,
debossed film-coated tablets containing 391.5 mg of clopidogrel bisulfate which
is the molar equivalent of 300 mg of clopidogrel base.

sudden headache, confusion, problems with vision, speech, or balance; or

pale skin, easy bruising or bleeding, weakness, fever, and urinating more or less than usual.

Less serious side effects may include:

stomach pain;

runny or stuffy nose, cough, sore throat; or

mild headache or dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about clopidogrel (Plavix)?

Clopidogrel keeps your blood from coagulating (clotting) to prevent unwanted blood clots that can occur with certain heart or blood vessel conditions. Because of this drug action, clopidogrel can make it easier for you to bleed, even from a minor injury. Contact your doctor or seek emergency medical attention if you have bleeding that will not stop.

You may also have bleeding on the inside of your body, such as in your stomach or intestines. Call your doctor at once if you have black or bloody stools, or if you cough up blood or vomit that looks like coffee grounds. These could be signs of bleeding in your digestive tract.

If you need to have any type of surgery or dental work, tell the surgeon or dentist ahead of time that you are using clopidogrel. You may need to stop using the medicine for at least 5 days before having surgery, to prevent excessive bleeding.